Description

Amiodarone-D4 Hcl is a deuterium-labeled internal standard of the antiarrhythmic drug Amiodarone, specifically designed for high-precision analytical applications. This stable isotope-labeled compound is essential for ensuring accurate quantification and reliable method validation in complex biological matrices. It is a critical material for pharmaceutical research and development, clinical laboratories, and forensic toxicology studies requiring the highest standards of analytical rigor.

Application

• Quantitative Bioanalysis: Serves as an internal standard in LC-MS/MS and GC-MS methods for the precise measurement of Amiodarone and its metabolites in plasma, serum, and tissue samples.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Therapeutic Drug Monitoring (TDM): Used in clinical laboratory assays to monitor Amiodarone levels in patient blood, aiding in dose optimization and minimizing toxicity risks.
• Forensic and Clinical Toxicology: Facilitates the definitive identification and quantification of Amiodarone in cases of overdose or adverse drug reaction investigations.
• Method Development and Validation: A key component for developing robust, sensitive, and selective analytical methods compliant with FDA, EMA, and ICH guidelines.
• Metabolite Identification and Profiling: Assists in the structural elucidation and quantification of drug metabolites during biotransformation studies.

Basic Information

Product Name	Amiodarone-D4 Hcl
CAS No.	1216715-80-8
Molecular Formula	C25H25D4I2NO3 • HCl
Molecular Weight	695.74 g/mol (for monoisotopic)
Synonyms	Amiodarone-d4 Hydrochloride; (2-Butyl-3-benzofuranyl)[4-[2-(diethyl-d4-amino)ethoxy]-3,5-diiodophenyl]methanone Hydrochloride; 2-Butyl-3-[4-(2-diethyl-d4-aminoethoxy)-3,5-diiodobenzoyl]benzofuran Hydrochloride; Cordarone-d4 HCl; Deuterated Amiodarone HCl; Amiodarone (diethyl-d4) Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Amiodarone-D4 Hcl is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity to meet the exacting demands of mass spectrometry. Comprehensive testing includes assay, isotopic enrichment (D4), and identification by NMR and MS. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting all critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This compound is hygroscopic (moisture-sensitive). For long-term storage, consider desiccant and under an inert atmosphere. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D4)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.